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Sinu-Phen

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Provision Medical Products
NDC Code: 69103-2536

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

UseS

temporarily relieves nasal congestion due

to the common cold, hay fever, or other

respiratory allergies.

helps decongest nasal and sinus passages

helps to temporarily relieve stu-y nose and

sinus pressure

If pregnant or breast-feeding, ask a health

professional before use.

KEEP OUT OF REACH OF CHILDREN. In

case of overdose, get medical help or

contact a Poison Control Center right

away.

Warnings:

Do not take this product if you have

any of the following:

heart disease • diabetes

high blood pressure • thyroid disease

or di culty in urination due to the enlargement

of the prostate gland

When using this product: DO NOT EXCEED

RECOMMENDED DOSAGE.

Stop use and ask a doctor if:

nervousness, dizziness or sleeplessness occur

symptoms do not improve within 7 days or are

accompanied by high fever

redness or swelling occur

Drug Interaction Precaution: Do not use this product if

you are now taking prescription monoamine oxidase

inhibitor (MAOI) (certain drugs for depression,

psychiatric or emotional conditions, or Parkinson's

disease), or for 2 weeks after stopping the MAOI drug. If

you are uncertain whether your prescription drug

contains an MAOI consult a health professional before

taking this product.

Directions:

Adults and children 12 years of age and older take 2 tablets

 every 4 hours, not exceed 12 tablets in

24 hours. Children 12 years and under  Do not use this adult strength product.

Please consult a physician before use.

Inactive Ingredients:

croscarmellose sodium, D&C red #27

lake, dicalcium phosphate,

magnesium stearate, microcrystalline

cellulose, pharmaceutical glaze,

pregelatinized starch, silica, sodium

starch glycolate, stearic acid and talc.

ACTIVE INGREDIENT-PHENYLEPHRINE HCl 5 MG

NASAL DECONGESTANT

SINU-PHEN 
phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2536
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
D&C RED NO. 27 
STEARIC ACID 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SHELLAC 
STARCH, PREGELATINIZED CORN 
TALC 
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeFR21
Contains    
Packaging
#Item CodePackage Description
1NDC:69103-2536-5250 PACKET in 1 CARTON
12 TABLET in 1 PACKET
2NDC:69103-2536-6100 PACKET in 1 CARTON
22 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/31/2015
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIOperations
Ultraseal Corporation085752004pack(69103-2536)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(69103-2536)

Revised: 04/2015
 
Provision Medical Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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